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ERBITUX
Colorectal and other GI cancers
Head and neck cancer
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Drug Name:

ERBITUX Rx

Generic Name and Formulations:
Cetuximab 100mg, 200mg; per vial; soln for IV infusion; preservative-free.

Company:
Lilly, Eli and Company

Therapeutic Use:

Indications for ERBITUX:

K-Ras (wild-type), EGFR-expressing metastatic colorectal cancer: for use in combination with FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) for first-line treatment, or in combination with irinotecan (if refractory to irinotecan-based chemotherapy), or as a single agent (after failure of both irinotecan- and oxaliplatin-based regimens or if irinotecan-intolerant).

Limitations Of use:

Not indicated for Ras mutant colorectal cancer that harbor somatic mutations in exon 2 (codons 12 and 13), exon 3 (codons 59 and 61), and exon 4 (codons 117 and 146) or when Ras mutation test results are unknown.

Adult:

Confirm EGFR expression status (using FDA-approved tests) and absence of Ras mutation prior to initiation. Pretreat with H1 blocker. Give by IV infusion (use filter); max rate: 10mg/min. Initial dose: 400mg/m2 once over 2hrs; then 250mg/m2 once weekly over 1hr until disease progression or unacceptable toxicity. Complete administration 1hr prior to FOLFIRI or irinotecan. Dose modifications for toxicity: see full labeling.

Children:

Not established.

Boxed Warning:

Infusion reactions. Cardiopulmonary arrest.

Warnings/Precautions:

Monitor for infusion reactions during and for ≥1hr post-infusion; if occurs, immediately interrupt and permanently discontinue based on severity. Increased risk of anaphylactic reactions with history of tick bites, red meat allergy, presence of IgE antibodies against galactose-α-1,3-galactose. Have emergency treatment readily available. Risk of cardiopulmonary arrest and/or sudden death; carefully consider use (w. irradiation or platinum-based therapy with 5-FU) in coronary artery disease, CHF, or arrhythmias. Interrupt for acute onset or worsening pulmonary symptoms; permanently discontinue if interstitial lung disease confirmed. Monitor for dermatologic toxicities (eg, acneiform rash, mucocutaneous disease) and infectious sequelae; withhold, reduce dose or permanently discontinue based on severity of reactions. Avoid sun exposure. Monitor electrolytes (eg, magnesium, potassium, calcium) during and for ≥8wks after cetuximab therapy. Embryo-fetal toxicity. Use effective contraception during and for 2 months after last dose. Pregnancy; exclude status prior to initiation. Nursing mothers: not recommended (during and for 2 months after last dose).

Pharmacological Class:

Epidermal growth factor receptor blocker.

Interactions:

Increased mucositis (Grade 3–4), radiation recall syndrome, acneiform rash, cardiac events, and electrolyte disturbances with radiation and cisplatin.

Adverse Reactions:

Cutaneous reactions (eg, rash, pruritus, nail changes), headache, diarrhea, infection; infusion reactions (may be severe), cardiopulmonary arrest, interstitial lung disease, dermatologic toxicities, electrolyte abnormalities (eg, hypomagnesemia).

Note:

Testing considerations: EGFR amplification analysis, K-RAS mutation analysis, B-RAF mutation analysis.

Generic Availability:

NO

How Supplied:

Single-use vials (50mL, 100mL)—1


Data provided by MPR.

Indications for ERBITUX:

In combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN). In combination with platinum-based therapy with 5-fluorouracil (5-FU) for first-line treatment of recurrent locoregional disease or metastatic SCCHN. As a single agent for recurrent or metastatic SCCHN after failure of prior platinum-based therapy.

Adult:

Pretreat with H1 blocker. Give by IV infusion (use filter); max rate: 10mg/min. Initial dose: 400mg/m2 once over 2hrs; then 250mg/m2 once weekly over 1hr. Combination therapy: Give initial dose 1 week prior to initiation of radiation therapy. Complete administration 1 hour prior to platinum-based therapy with 5-FU. Give subsequent weekly dose for duration of radiation therapy (6–7 weeks) or until disease progression or unacceptable toxicity. Dose modifications for toxicity: see full labeling.

Children:

Not established.

Boxed Warning:

Infusion reactions. Cardiopulmonary arrest.

Warnings/Precautions:

Monitor for infusion reactions during and for ≥1hr post-infusion; if occurs, immediately interrupt and permanently discontinue based on severity. Increased risk of anaphylactic reactions with history of tick bites, red meat allergy, presence of IgE antibodies against galactose-α-1,3-galactose. Have emergency treatment readily available. Risk of cardiopulmonary arrest and/or sudden death; carefully consider use (w. irradiation or platinum-based therapy with 5-FU) in coronary artery disease, CHF, or arrhythmias. Interrupt for acute onset or worsening pulmonary symptoms; permanently discontinue if interstitial lung disease confirmed. Monitor for dermatologic toxicities (eg, acneiform rash, mucocutaneous disease) and infectious sequelae; withhold, reduce dose or permanently discontinue based on severity of reactions. Avoid sun exposure. Monitor electrolytes (eg, magnesium, potassium, calcium) during and for ≥8wks after cetuximab therapy. Embryo-fetal toxicity. Use effective contraception during and for 2 months after last dose. Pregnancy; exclude status prior to initiation. Nursing mothers: not recommended (during and for 2 months after last dose).

Pharmacological Class:

Epidermal growth factor receptor blocker.

Interactions:

Increased mucositis (Grade 3–4), radiation recall syndrome, acneiform rash, cardiac events, and electrolyte disturbances with radiation and cisplatin.

Adverse Reactions:

Cutaneous reactions (eg, rash, pruritus, nail changes), headache, diarrhea, infection; infusion reactions (may be severe), cardiopulmonary arrest, interstitial lung disease, dermatologic toxicities, electrolyte abnormalities (eg, hypomagnesemia).

Generic Availability:

NO

How Supplied:

Single-use vials (50mL, 100mL)—1


Data provided by MPR.

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